Identity
- Trade Name
- Pantaject® 3mL EUDAMED
- Device Name
- Set For Applying Beriplast P (tradename Pantaject®) EUDAMED
- Model / Reference
- 5000586 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640255020380 EUDAMED
- Basic UDI-DI
- 764025502EM.CSL.0102GS EUDAMED
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Pantaject® 3mL by Effectum Medical AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764025502EM.CSL.0102GS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Effectum Medical AG
- EUDAMED SRN
- CH-MF-000012474
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 3364342c-3783-44fe-bbff-c38fe68c8b64 61 fields · synced Jul 9, 2026